Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fraction

This research is investigating a medicine called Trimeductan MR for individuals who have a specific type of heart failure. This type of heart failure is known as 'heart failure with preserved ejection fraction,' which means the heart can still pump blood out to the body with normal strength, but it struggles to fill properly. The study aims to find out if Trimeductan MR can help reduce the number of times people need to go to the hospital because their heart failure gets worse, or if it can help prevent early death related to heart problems. Researchers will also look at how the medicine affects different measures of heart health and general well-being. Participants will either receive the active medicine or a dummy pill (placebo) to see if Trimeductan MR really makes a difference.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Medical University Of Gdansk

Enrolment target

468

Start

12 Jan 2024

Heart failure with preserved ejection fraction

What is this study about?

This study is designed to learn more about a medicine called Trimeductan MR and its effects on people living with a specific kind of heart failure. This type is called 'heart failure with preserved ejection fraction.' What this means is that your heart’s main pumping chamber (the left ventricle) can still squeeze blood out to your body with normal force. However, the problem lies in the heart muscle becoming stiff, making it harder for the chamber to relax and fill up with enough blood between beats. This can still lead to symptoms like breathlessness and tiredness.

The main goal of the study is to see if taking Trimeductan MR can reduce the risk of you needing to be admitted to the hospital because your heart failure symptoms get worse. It also wants to find out if the medicine can help prevent death from heart-related conditions. This is a 'Phase IV' study, which means the medicine has already been approved and is being used, but researchers are gathering more information about its long-term effects and benefits in real-world settings.

To understand the full picture, the researchers will also be looking at several other important things. This includes how long people stay out of the hospital for any health reason, how their overall quality of life changes (using special questionnaires), and if there are improvements in their heart function and how their blood vessels work. They will also measure certain substances in the blood that can tell them about inflammation and heart health. By carefully comparing those who receive the active medicine with those who receive a dummy pill, the study hopes to clearly show whether Trimeductan MR can make a meaningful difference for people with this condition.

Key takeaways

This study is for adults with a specific type of heart failure.
It tests if a medicine called Trimeductan MR can reduce hospital stays.
You might receive the active medicine or a dummy pill.
Regular health checks and tests will be part of your participation.
It's a Phase IV study, gathering more information on an existing treatment.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages are welcome to be considered.

Both men and women can take part in this research. The study is open to anyone, regardless of their gender.

The most important requirement is that you have a diagnosis of 'heart failure with preserved ejection fraction.' This is a specific type of heart failure where your heart muscle can still pump strongly, but it has trouble relaxing and filling with blood properly.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with 'heart failure with preserved ejection fraction'?
Are you comfortable with the idea of potentially taking a dummy pill?
Are you able to attend regular study visits and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the active medicine, Trimeductan MR, or a dummy tablet (placebo). This means neither you nor your study doctor will know which one you are getting, to make sure the results are fair. Both the active medicine and the placebo would be taken as modified-release tablets, usually once a day.

Your participation would involve regular visits to the clinic for assessments. During these visits, the study team would check your health, ask about your symptoms, and carry out various tests. These tests might include blood samples to look at your heart health and inflammation, heart scans, and assessments to measure how well your blood vessels are working. You would also complete questionnaires about your quality of life. The study will continue for a certain period, and you will have follow-up appointments to monitor your progress and safety. The total duration of your participation would be explained fully before you join.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving close medical attention and potentially benefiting from a new treatment before it's widely available. However, there are also potential risks; for instance, you might experience side effects from the study medication, or the treatment might not work for you. Since you could be receiving a dummy pill, there's a chance you might not get the active treatment. All known risks will be fully explained before you agree to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is 'heart failure with preserved ejection fraction'?

It's a type of heart failure where your heart can still pump blood strongly, but it has trouble relaxing and filling with enough blood between beats.

What is Trimeductan MR and how does it work?

Trimeductan MR is a medicine being studied. The researchers want to see if it can help improve heart health and reduce hospital stays for people with heart failure.

Why would I receive a 'dummy pill'?

Some participants receive a dummy pill (placebo) to help researchers fairly compare the active medicine's effects against no active treatment. This ensures the results are reliable.

How long will I be in the study?

The exact duration of your participation will be explained by the study team, as it can vary. You will have regular check-ups throughout the study period.

What tests will I have if I join?

You might have blood tests, heart scans, assessments of your blood vessel function, and questionnaires about your health and quality of life.